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Lead Product(s): Bromelain
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: NexoBrid
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
The completion of the CIDS enrollment stage follows the U.S. Food and Drug Administration (FDA)’s recent agreement to allow the NexoBrid expanded access (NEXT) protocol to be expanded to include pediatric as well as adult burn patients.
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Lead Product(s): Bromelain
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: NexoBrid
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2020
Details:
The BLA submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal U.S. Phase 3 study of NexoBrid in adult patients with deep partial and/or full-thickness thermal burns up to 30% of total body surface area.
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Lead Product(s): Bromelain
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: NexoBrid
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2020
Details:
The BLA submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal U.S. Phase 3 study of NexoBrid in adult patients with deep partial and full-thickness thermal burns.
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